CareSpec 7-56442

GUDID 20816908010713

Vaginal Speculum, Single-Use (Medium, Screw Closure)

CYALUME TECHNOLOGIES, INC.

Vaginal speculum, single-use

• Primary Device ID: 20816908010713
• NIH Device Record Key: 0cf212c6-5880-4024-9dbd-400790ae6b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSpec
• Version Model Number: 7-56442
• Catalog Number: 7-56442
• Company DUNS: 154779748
• Company Name: CYALUME TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-733-4034
• Email: info@cyalumemed.com
• Phone: 1-888-733-4034
• Email: info@cyalumemed.com
• Phone: 1-888-733-4034
• Email: info@cyalumemed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816908010719 [Primary]
GS1	10816908010716 [Package]; Contains: 00816908010719; Package: Inner Pack [25 Units]; In Commercial Distribution
GS1	20816908010713 [Package]; Contains: 10816908010716; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-02
• Device Publish Date: 2018-03-01

On-Brand Devices [CareSpec]

• 20816908010720: Vaginal Speculum, Single-Use (Large, Screw Closure)
• 20816908010713: Vaginal Speculum, Single-Use (Medium, Screw Closure)
• 20816908010706: Vaginal Speculum, Single-Use (Small, Screw Closure)